Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colon and Colorectal Cancer Patients: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
研究概览
简要总结
The primary purpose of the trial is to determine the preliminary efficacy of therapeutic ultrasound in the treatment of pain and sensory disturbance related to chemotherapy induced peripheral neuropathy.
详细描述
Thirty cancer patients with colon or colorectal cancer undergoing chemotherapy treatment including the agent oxaliplatin will take part in the study. Patients will be randomly assigned to either standard care alone (education and therapeutic exercises) or standard care plus 10 treatments of therapeutic ultrasound to the toes and fingers.
Participants in both groups will follow a home exercise program for a 6 week period. Therapeutic ultrasound will be administered daily (e.g., Monday to Friday) over the first two week period of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults18 or older,
- •receiving or have received chemotherapy treatment for colon or colorectal cancer,
- •chemotherapy regimen includes the agent oxaliplatin,
- •Grade 1, 2 or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy.
排除标准
- •neuropathy pre-existing the patient's cancer diagnosis;
- •contraindications to therapeutic ultrasound:
- •active cancer in region of hands or feet,
- •presence of deep vein thrombosis,
- •lack of sensation in hands or feet,
- •metal or plastic implants in hands or feet;
- •peripheral vascular disease or other serious existing non-malignant disease which may affect their ability to complete testing and treatment sessions.
研究组 & 干预措施
Standard Care
Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home.
干预措施: Standard Care (Behavioral)
Experimental: Ultrasound Therapy
Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home. Participants in this group will also undergo 10 daily treatments of ultrasound therapy (e.g., Monday to Friday for two weeks) that is administered to their toes and fingers. The ultrasound therapy will be administered over the first two weeks of the intervention period.
干预措施: Standard Care (Behavioral)
Experimental: Ultrasound Therapy
Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home. Participants in this group will also undergo 10 daily treatments of ultrasound therapy (e.g., Monday to Friday for two weeks) that is administered to their toes and fingers. The ultrasound therapy will be administered over the first two weeks of the intervention period.
干预措施: Ultrasound Therapy (Other)
结局指标
主要结局
Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
时间窗: 6 weeks
Change in pain and sensory disturbance
次要结局
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3(6 weeks)
- Protective sensation(6 weeks)
- Temperature sensation(6 weeks)
- Vibration sensation(6 weeks)
- Reflexes(6 weeks)
- Balance Assessment(6 weeks)
研究者
Margie McNeely
Associate Professor
University of Alberta